Director, Biomarkers Mood Disorders

Job description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Director, Biomarkers Mood Disoders, located in La Jolla, CA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.

Responsible for the development of the biomarker strategy within the mood disease area stronghold (DAS) and its integration with the overall discovery, translation and clinical development efforts. Tasked with working with discovery and biomarker scientists and the compound development teams on overseeing the direction, planning, execution, and interpretation of clinical trials research, data collection and analysis activities and clinical operations as they relate to biomarkers.

The Director, Biomarkers Mood Disorders will:
• Account for all mood DAS biomarker needs in support of all compounds in Discovery, Experimental Medicine, and Clinical Development.
• Refine / revise the biomarker strategy for mood DAS research and development.
• Interface with internal and external experts in relevant biomarker platforms to contribute to the development of a multimodal biomarker strategy.
• Lead biomarker efforts for all mood DAS compounds, and provide input for project prioritization within the mood DAS.
• Interface with internal R&D and commercial colleagues to lead biomarker strategies that will inform and improve decision-making for the neuroscience portfolio.
• Provide input to compound development and clinical teams, and supervise the biomarker-related aspects of pre-clinical and clinical studies to effect biomarker utilization, validation and application.
• Link biomarker strategy to protocol design, development, implementation and execution of mood DAS projects; liaise with the Clinical Operations and Biomarker Operations Teams to facilitate implementation.
• Integrate across biomarker working groups to ensure alignment of strategies and plans with the overall biomarker strategy. Review an update biomarker strategy to ensure alignment with the overall goals of the mood DAS.
• Interact with investigational sites, clinical consultants, Contract Research Organizations (CRO) and other vendors as necessary. Monitor adherence to protocols and assess study completion.
• Work with statisticians and the biomarker signatures team on data analysis and interpretation, and communicate results to internal and external stakeholders.
• Remain current on the evolving landscape of biomarker technologies and applications, study methodologies, assessment tools and relevant drug mechanisms of action.
• Form collaborations with academia, industrial consortia and commercial vendors to optimize support of neuroscience biomarkers.

Desired profile

Qualifications :

• A minimum of an MD or Ph.D is required.
• A minimum of 12 years of progressive experience in life sciences or medicine, including 8+ years of experience in the biopharmaceutical industry or academics, or related experience including previous supervisory or leadership roles is required.
• Proven track record of scientific contributions both internally (advancing discovery programs to clinical candidates) and externally (peer reviewed publications, patents, and presentations is required.
• A minimum of 10 years of experience in research related to biomarkers in psychiatric disorders is required.
• A minimum of 3 years of experience with implementing biomarkers in clinical research is required, which must include driving the development of clinical research protocols for testing biomarker hypotheses and overseeing execution of the trial. Preferred is 5 or more years of experience.
• Demonstrated scientific contribution in neuroscience research with emphasis on biomarkers in psychiatric illness is preferred.
• Working knowledge of the concepts of clinical research and drug development is preferred.
• Proven ability to provide scientifically well-founded and pragmatic biomarker hypotheses for implementation in clinical research is preferred.
• Knowledge to evaluate strategies for testing biomarker hypotheses in clinical development and to critically evaluate outside expert advice is preferred.
• Strong scientific/technical leadership skills and demonstrated ability to build successful relationships with internal and external partners globally is preferred.